Inspections, Compliance, Enforcement, and Criminal Investigations

GliSODin Skin Nutrients 5/18/18

 

  

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WARNING LETTER

MAY 18 2018

VIA EXPRESS DELIVERY

Corina Crysler, Co-Founder
GliSODin Skin Nutrients
503-639 Queen St. W.
Toronto, Ontario M5V 2B7
Canada
Re: 552094

This is to advise you that the United States Food and Drug Administration (FDA) reviewed your website at the Internet address https://www.glisodinskin.com/ in March 2018 and has determined that you take orders there for the product Advanced Skin Brightening Formula. In addition, FDA reviewed your product label and labeling after purchasing your product from your website. The claims on your website and product labeling establish that the product is as drug under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(B)] because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease. As explained further below, introducing or delivering this product for introduction into interstate commerce for such uses violates the Act.  You can find the Act and FDA regulations through links on FDA’s home page at www.fda.gov

Examples of some of the website claims that provide evidence that your Advanced Skin Brightening Formula product is intended for use as a drug include:

• “Are you aware that skin cancer is the most common form of cancer diagnosed in North America? ... The good news is there is a simple and natural way to strengthen your skin’s defenses against ultraviolet radiation in the form of a daily supplement designed to improve skin health.” 
• “The Advanced Skin Brightening Formula contains ingredients that reduce oxidative stress (one of the harmful effects of UV light)..."

An example of a product brochure claim that provides evidence that your Advanced Skin Brightening Formula product is intended for use as a drug includes:

• “Enhances photoprotection…”

Your Advanced Skin Brightening Formula product is not generally recognized as safe and effective for the above referenced uses and, therefore, the product is a “new drug” under section 201(p) of the Act [21 U.S.C. § 321(p)].  New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in sections 301(d) and 505(a) of the Act [21 U.S.C. §§ 331(d), 355(a)].  FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective. 

This letter is not an all-inclusive statement of violations associated with your product or its labeling, and we have not attempted to list here all of the products that are promoted on your website for intended uses that cause them to be drugs.  It is your responsibility to ensure that all products marketed by your firm comply with the Act and its implementing regulations.  We advise you to review your website, product labels, and other labeling for your products to ensure that the claims you make for your products do not reflect intended uses that cause the distribution of the products to violate the Act.

We request that you take prompt action to correct all violations associated with your products, including the violations identified in this letter. Failure to do so may result in further action without notice. For instance, we may refuse admission of your products under section 801(a) of the Act [21 U.S.C. §381(a)], including placing them on detention without physical examination (DWPE). FDA's DWPE is an administrative procedure whereby products offered for import into the United States may be detained without physical examination upon entry. DWPE information may be conveyed in FDA's Import Alerts. For your information, an example of an Import Alert that conveys information specific to foreign firms that are not in compliance with section 505(a) of the Act is Import Alert #66-41, “Detention Without Physical Examination of Unapproved New Drugs Promoted in the U.S.” This alert can be found on FDA's web site at: https://www.accessdata.fda.gov/cms_ia/importalert_190.html.

If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration. Please notify this office in writing within fifteen (15) working days of the receipt of this letter as to the specific steps you have taken to correct the stated violations, including an explanation of each step being taken to identify violations and make corrections to ensure that similar violations will not recur. If the corrective action cannot be completed within fifteen working days, state the reason for the delay and the time frame within which the corrections will be implemented.

You should direct your written reply to Beth Tirio, Food and Drug Administration, Center for Food Safety and Applied Nutrition, 5001 Campus Drive, Office of Compliance (HFS-608), Division of Enforcement, College Park, Maryland 20740-3835. If you have any questions regarding this letter, you may contact Ms. Tirio via email at beth.tirio@fda.hhs.gov.

Sincerely,
/s/     
William Correll
Director
Office of Compliance
Center for Food Safety and Applied Nutrition
US Food and Drug Administration
 

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